Effect of Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass on Gastroesophageal Reflux Disease: An 8-Year Prospective Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gastroesophageal Reflux Disease, Morbid Obesity. Basic parameters: 18 years — 78 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass on Gastroesophageal Reflux Disease: An 8-Year Prospective Cohort Study.
Overview
This study represents a long-term observational follow-up of patients who had previously undergone bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass) in the context of an earlier interventional trial (NCT03692455). No new interventions are assigned in the follow-up phase. Participants are evaluated clinically and functionally at predefined intervals using standardized multimodal assessments (symptom questionnaires, endoscopy, manometry, radiology, and pH monitoring).
Detailed description
In order to determine the long term impact of Bariatric surgery on GERD, esophageal syndromes will be evaluated following the Lyon 2.0 Consensus, where troublesome symptoms were defined as score ≥ 2 on a validated questionnaire of symptoms for Portuguese language along with esophageal syndromes with injury assessed through upper endoscopy.
Esophageal acid exposure will be determined through 24h pH monitoring. Increased acid exposure will be characterized when total esophageal pH \< 4 for at least 4% of its total monitoring time. The data will be collected 8 years after de surgical intervention.
Primary outcome measures
- Change in number of Participants With Gastroesophageal Reflux Disease (GERD) [Time frame: 8 years after intervention]
Secondary outcome measures (6)
- Change in number of Participants Presenting GERD symptoms [Time frame: 8 years after intervention]
- Change in number of Participants With Esophageal Injury [Time frame: 8 years after intervention]
- Change in Total Esophageal Acid Exposure at 24h pH Monitoring [Time frame: 8 years after intervention]
- Change in Esophageal Acid Exposure at 24h pH Monitoring in Upright Position [Time frame: 8 years after intervention]
- Change in Esophageal Acid Exposure at 24h pH Monitoring in Supine Position [Time frame: 8 years after intervention]
- Change in number of Participants With Increased Acid Exposure [Time frame: 8 years after intervention]
Eligibility criteria
Inclusion criteria
Patients enrolled in a previous prospective dual-cohort extension with 75 patients of the original Trial.
Original Inclusion Criteria: Inclusion criteria were age 18-70 years and body mass index (BMI) ≥40 kg/m², or ≥35 kg/m² with obesity-related comorbidities. A total of 75 patients completed the original trial.
Exclusion Criteria: Been previously submitted to any gastroesophageal surgical procedure. Presence of chronical diseases that affects esophageal motility. Do not tolerate any of the required exams
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 1 center
- Gastrobese Clinic — Passo Fundo
Publications
- Navarini D, Madalosso CAS, Fornari F, Tognon AP, Ghiasson C, Scortegagna GT, Gurski RR. Gastroesophageal Reflux Disease After Sleeve Gastrectomy versus Roux-en-Y Gastric Bypass: An 8-Year Prospective Cohort Study. World J Surg. 2026 Jun;50(6):1460-1467. doi: 10.1002/wjs.70367. Epub 2026 Apr 12. PMID 41968616
Identifiers
NCT: NCT03692455 · PP3 Folow-up